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ISPE’s Regulatory and Quality Initiatives Featured at the 2023 ISPE Annual Meeting & Expo

Jessica Lo Surdo, PhD
Michael Grischeau
Regulatory Panel - ISPE 2023 Annual Meeting & Expo

The ISPE 2023 Annual Meeting & Expo agenda is always packed with sessions offering pharmaceutical professionals opportunities to engage in industry-critical conversations. Several of ISPE's regulatory initiatives took center stage during the technical sessions in the Regulatory and Quality track at the 2023 ISPE Annual Meeting & Expo in Las Vegas, NV, USA.

Updates to ICH Quality Topics

The Updates to ICH Quality Topics session, facilitated by Connie Langer, Director at Pfizer Global Regulatory Sciences, CMC, included a series of five lightning talks on ICH Q12, ICH Q14 and M4Q, which demonstrated the interrelationship between these quality guidances and the benefits of harmonization.

Sarah Pope Miksinski, PhD, Executive Director, CMC Regulatory Affairs at Gilead Sciences, Inc., and chair of ISPE’s Regulatory Steering Council, opened the session with a discussion of the vision for ICH M4Q(R2), and how industry can put an application together in such a way that conveys a story efficiently. There are a number of opportunities for M4Q(R2), including innovation and enabling knowledge management, which help drive efficiencies and ultimately benefits patients. Key objectives of the M4Q revision were described, including global harmonization, minimizing GMP documents in the dossier, enabling full use of ICH guidelines Q8-Q14, preparing for structured data submissions and ultimately, telling the product story and linking it to the patient.

Tara Scherder, Principal at SynoloStats and a member of several ISPE PQLI® technical teams, spoke to the power of statistical methods used during process development and design of experiments. With the recent draft version of ICH Q14 released, she presented examples and discussed how statistical methods can be leveraged to proficiently meet the critical aspects of the analytical procedure lifecycle management per this guideline.

Eli Zavialov, PhD, Senior Director at GlaxoSmithKline and member of ISPE’s Q12 Implementation technical team, discussed challenges related to global adoption and implementation of ICH Q12 for both industry and health authorities. Currently, the United States, Japan and China, with some caveats, have fully implemented ICH Q12, with partial implementation underway in several markets. He elaborated on GSK’s experience and the benefit of ICH Q12 in reducing the number of established conditions by initially focusing only on the drug substance and drug product process parameter sections of the CMC dossier.

Expanding on ICH Q12, Ben Stevens, Director at GlaxoSmithKline and a member of ISPE’s Regulatory Quality Harmonization Committee’s North America regional group, elaborated on the benefits of ICH Q12, specifically Post-Approval Change Management Protocols (PACMPs). PACMPs are the most widely-used ICH Q12 tool globally based on a 2022 survey of industry practices, with their utility being highlighted during the COVID-19 pandemic.

The final update was presented by Mahesh Ramanadham, FDA Deputy Director for the Office of Policy for Pharmaceutical Quality, described FDA’s current implementation experience with ICH Q12. Commander (CDR) Ramanadham spoke to the role of the FDA assessor in inspection support of the PQS as it relates to ICH Q12, with the addition of two teams that have been formed to aid in training, oversight and support of FDA implementation of ICH Q12. FDA is engaged in broader efforts to encourage use of ICH Q12, through engagement in working groups, pilot programs, and sharing their experiences with other regulators.

The session closed with an interactive panel discussion with the presenters, with most questions focusing on aspects of ICH Q12 and associated trends.

Quality Management Maturity (QMM) in Action

ISPE’s Advancing Pharmaceutical Quality (APQ) team hosted a successful and interactive session on Quality Management Maturity (QMM) in Action, with participation by CDR Marcus Yambot, Senior Consumer Safety Officer from FDA CDER’s Office of Quality Surveillance (OQS).

Session attendees received an update from CDR Yambot on the FDA’s ongoing QMM program development and had an opportunity to get “hands on” with the APQ program, where APQ team members shared practical examples from each guide series in an interactive and collaborative workshop format. The session feedback was overwhelmingly positive regarding the open dialogue between industry peers and access to APQ guide writers to answer questions in real time. When it comes to engagement, there was over an 80% participation rate from attendees.

ISPE’s APQ program has been developed by industry representatives, for industry use, to advance the current state of pharmaceutical quality by providing practical tools and approaches to enhance the effectiveness of the Pharmaceutical Quality System (PQS). The APQ program is intended to provide a practical framework that an organization can use to first assess the maturity and then advance the state of quality within their organization. It is a quality management maturity program that aims to identify good practices and good behaviors which support the continual improvement of quality management effectiveness within an organization.

The program is aligned with international initiatives that promote quality excellence, as well as with the FDA’s interest in quality management maturity and rating the maturity of manufacturing facilities, as cited in their 2019 Drug Shortages report. The APQ program recognizes that the ability to advance the maturity of quality management lies within the industry itself and a key driver for this program is to provide a range of sustainable and practical quality management improvement strategies. The APQ program offers a distinctive approach that enables users to prioritize and optimize the program's effectiveness by focusing on a specific element, multiple elements, or all elements. This flexibility allows users to tailor the program to their needs and goals, ensuring that they can achieve the desired outcomes efficiently and effectively.

During the QMM in Action session, participants were walked through examples on how to assess and improve a PQS element of their choice as described in ICH Q10 using the APQ Assess, Aspire, Act & Advance Framework, and were given the opportunity to exchange input and ideas on how to assess and improve the effectiveness their own pharmaceutical quality systems.

CDR Yambot spoke to complementary approaches on the importance of addressing supply and demand-driven shortages in the pharmaceutical industry. He mentioned the need for innovative approaches, transitioning from lagging indicators to leading methods driven by a Quality Maturity Model (QMM). In the 2019 report, Drug Shortages: Root Causes and Potential Solutions, the FDA found that the market doesn't reward manufacturers for mature quality systems that focus on continual improvement and early supply chain issue detection. To address this, the FDA proposed a QMM rating program to incentivize manufacturers to invest in culture, continual improvement, and innovation. QMM is defined as a way for drug manufacturers to integrate business and manufacturing operations with quality practices and technology to enhance product quality, supply chain reliability, and continual improvement. The rating program aims to provide a higher assurance of product availability based on QMM assessments.

QMM is a qualitative and holistic measurement of behaviors and systems across five proposed practice areas: Management Commitment to Quality, Business Continuity, Advanced Pharmaceutical Quality System (PQS), Technical Excellence, and Employee Empowerment and Engagement. This voluntary program is intended to recognize performance beyond basic good manufacturing practices (GMPs). It is also important to recognize that a QMM evaluation is different from a GMP surveillance inspection and would be conducted separately.

The FDA's QMM program is a long-term initiative developed with input from industry and stakeholders. Recent developments include two pilot programs completed in 2022 and the release of various documents and publications related to QMM: CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol White Paper Development (September 2023), Office of Pharmaceutical Quality (OPQ) White Paper (April 2022), CDER Small Business and Industry Assistance BIA Quality Management Maturity Workshop (May 2022), the FDA Advisory Committee (November 2022). CDR Yambot mentioned that the FDA is still finalizing certain operational aspects, such as eligibility criteria, whether assessments will be conducted by the FDA or third parties, remote or on-site components, reassessments, presentation of results, and the potential release of information. The rubric is under development leveraging learnings from their pilots, research results, public feedback, and work by industry associations, such as ISPE’s Advancing Pharmaceutical Quality (APQ) Program. In September 2023, the FDA announced the establishment of a docket to gather public comments, which will aid the Agency in further shaping the QMM program.

Related content: ISPE’s APQ team recognized as ISPE’s 2023 Committee of the Year


This is an informal summary of sessions held at the 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, USA. It has not been vetted by any of the agencies or regulators cited in this article, should not be considered the official positions of any of the agencies referenced.